Safety Study of Inhaled 552-02 in Cystic Fibrosis Patients

Inclusion criteria

• Male and female patients aged > 14 years.
• Patients who are diagnosed with cystic fibrosis.
• Patients who have a FEV1 ≥ 50% predicted (post-bronchodilator) at screening.
• Patients who are able to perform reproducible spirometry according to ATS guidelines.
• Patients who have an oxygen saturation of ≥ 92% on room air as determined by pulse oximetry at screening.

Exclusion criteria

• Patients who have a FEV1 change ≥ 15% after bronchodilator use at screening.
• Patients who have unstable lung disease as defined by the requirement for intravenous antibiotics during the four weeks prior to screening, a change in medical regimen within 14 days prior to administration of the first dose of study drug or during the 14 day treatment period, a FEV1 ≥ 15% below recent (within six months) clinical measurements, or significant new findings on chest radiograph (pneumothorax, lobar/segmental collapse) that are not considered a part of the usual, chronic progression of cystic fibrosis lung disease.
• Patients on angiotensin converting enzyme (ACE) inhibitors.
• Patients with renal insufficiency as evidenced by hyperkalemia (blood potassium levels greater than 5.5 mEq/L) or serum creatinine > 2.0 mg/dL.
• Patients who have a history of drug allergies to any medicine chemically related to the study drug (e.g. amiloride, Moduretic, Midamor; triamterene).
• Patients who are pregnant, have a positive pregnancy test, or are nursing.
• Patients who have had a lung transplant.